Going Bionic: Test Drive of an Artificial Pancreas System

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In our continuing coverage of all things closed loop, today we're excited to share the experiences of a long-time type 1 in the Boston area who's recently had the chance to try out the much-discussed Bionic Pancreas system -- our friend and fellow diabetes advocateBernard Farrell.

The Bionic Pancreas is of course being developed by Dr. Ed Damiano and Dr. Steven Russell from Boston University. We've written about their work before, and it's been making huge strides in the past couple years (something I'm personally very excited about).

At the recent American Diabetes Association's Scientific Sessions, Damiano reported that his team expects to do some more key trials soon that include testing how their system functions using insulin only, without glucagon -- which has been included until now. That will provide important insight before they head into the pivotal trial phase, in hopes of introducing a commercial product by 2018.

We shall see, but in the meantime it's encouraging to hear how fellow D-peeps are using this next-gen tech during trial runs.

Without further ado, let's hear from Bernard about how it went...

A Guest Post by Bernard Farrell

I’ve had type 1 diabetes for over 40 years. In that time,
I’ve had a chance to use three significant pieces of technology that are diabetes
life-changers for me: blood glucose meters, insulin pumps and continuous
glucose monitors (CGMs).

Now, the next-generation system that's in development is the Artificial Pancreas, and it brings together -- or closes the loop -- between all three of those life-changing devices.

Recently I had a chance to participate in a trial to support
the closed loop research being done by Dr. Ed Damiano and his team at Boston
University. They call it the Bionic Pancreas.
Based on using a prototype device to improve my blood glucose (BG) control and
improve the quality of my life, I plan to get one of these as soon as they’re on
the market.

I'm not the first to go through this trial, of course. You may have already read about previous trials for this
research, the Beacon Hill Study in 2013 where folks had a chance to live with the Bionic Pancreas while they roamed
around the Beacon Hill area in Boston. If that sounds restrictive it wasn’t;
reading some of the postings afterwards makes it clear that although the
equipment was prototypes, the results were astounding. Last year, some kids at the Clara Barton diabetes camp also
had a chance to wear the BP and see the amazing results.
It’s clear to me the BP team is using real-world situations to push the
boundaries on this technology and produce great results.

Despite my pump and CGM, managing my BG control is still a
huge amount of work. I have too many days when I can’t tame my rollercoaster
blood sugars or can’t get my BG levels into any kind of reasonable range. So
when offered a place in this latest trial, I didn’t hesitate.

This trial investigated whether using automated glucagon delivery
can better control BG levels. The setup was that participants were each given a Tandem t:slim insulin pump for glucagon or placebo
delivery; a Dexcom CGM for BG monitoring; and another device referred to as
the Bionic Pancreas.

File photo of Bionic Pancreas system; not what Bernard used, as he had a double-blinded device where he couldn't see the actual data.

The BP itself is a large, heavy, case that holds both an
iPhone and a Dexcom receiver. (I think the extra weight is due to a battery
that powers the combination.) Both the pump and Dexcom had Bluetooth
connections to the iPhone. The iPhone took the Dexcom reading (every 5 minutes)
and decided whether some glucagon was needed. It also transmitted all the
information to the cloud, so the team knew if there were any issues with
connections.

The BP Dexcom readings were hidden from me, but I continued
to wear my own Dexcom setup and used that as usual to decide on insulin dosing.
The glucagon pump was also essentially disabled for me; the only thing I could do
was enable or disable Bluetooth. Here's what the glucagon-pump screen looked like:

This was a double-blind study. That means neither the
researchers nor myself knew whether I was getting glucagon or a placebo on a
given day. Currently a liquid solution of glucagon is only stable for about 27 hours,
so I had to change out the extra pump set around the same time every day. This was
the only difficult part of the study. We were given a daily supply of the
liquid to use; it was contained inside black cylinders so we didn’t know
whether we were filling the pump with glucagon or the placebo. These cylinders
made it hard to get the liquid out. This daily routine was truly the hardest
part of the trial. There was also a daily survey at the end of each 24
hours that asked questions about any nausea I felt, how many lows I
experienced, and if I thought I was using a placebo or glucagon and why.

The study folks were careful about setting expectations and
making sure we all understood how everything worked and how to deal with any error
messages. For the two-week duration of the study there was always someone on call. I was
called a total of three times because the BP had lost the connection to the
pump and needed to be reconnected.

OK, enough about the nuts and bolts. How did it work in real life?

First of all, I knew there were several days when I was
getting real glucagon. I never experienced any nausea, the doses delivered are
much smaller than you’d get from a glucagon injection. But this was a pleasant
surprise.

How could I tell when there was glucagon? My Dexcom graph
gave it away. Below, you can see my
BG dropping really fast from a big high -- magically when it gets to a certain number.

I did catch the Tandem pump dosing too because it
sometimes buzzed. So I could ‘see’ how many units it was giving me though I couldn’t
tell whether it was glucagon or placebo. Glucagon concentration peaks within about 20 minutes
and tails off very quickly, in about 90 minutes. So I did notice times when I
was given several ‘glucagon’ boluses over a few hours. Around 120
mg/dL it changes direction and levels out. Then it starts to drop later and is pulled
up again. By the time I went to sleep around midnight, I didn’t worry too much
about further drops because of the results from 3:30 pm onwards.

In the Beacon Hill Study, participants could notify the Bionic Pancreas
that they were eating a meal. For this study, we couldn’t do that, which is one of
the things I find amazing. The BP didn’t know whether I was exercising,
eating, or had taken an insulin bolus. But it did a great job at maintaining my
BG levels within a fairly tight range.

What were the downsides? It was a challenge to wear two
Dexcom sensors. And changing the
glucagon site every day was an effort and hard to remember. I ended up setting
a reminder because I’d forget and get to it a few hours late. Several times the
two sets of tubing were tangled and wearing two pumps was a challenge to my
waistline. But…

This is a prototype setup. In 2013, JDRF announced it was
working with Tandem on a dual-chamber infusion pump. Glucagon stability is difficult but several companies (Calibrium and Xeris) and
research projects seem to be working on this issue and hopefully this will be
solved before long. Ideally a solution will allow a single site that delivers
both insulin and glucagon in the same cannula, but if two cannulas are needed
and can be provided in a single insertable unit that should work for many
folks.

My sincere hope is that this research moves quickly into
product development. I don’t know whether the research already completed,
including this trial, will count as Phase I and
Phase II trials for the FDA. But the practical experience gained in running the
research and gathering results should enable the BP team to effectively
complete all needed FDA trials.

What I see as the biggest challenge is cost and insurance
coverage. Pumps and CGMs are now covered for type 1 diabetes by many insurance
companies, but this technical development will cost more initially and
insurance providers may hold back on reimbursement until it’s been proven.

Dr. Ed Damiano started work on this project after his son
David was diagnosed with type 1 diabetes as an infant. Damiano wanted to make
living with diabetes much easier and he’s hoping to get the BP on the market
before David leaves for college -- that’s in about two years' time.

Given all he’s accomplished in the last 14
years, my money is on the success of this project. And unlike ‘the cure’
(whatever that may be) this should be in our hands before 10 years are up.

Thanks for sharing, Bernard. Sounds exciting, even with the double-blinded aspect. Needless to say, we look forward to seeing how the research moves forward!

Disclaimer: Content created by the Diabetes Mine team. For more
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Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community.
The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines.
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